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1
Introduction
T
he US Food and Drug Administration (FDA), through its Center for
Devices and Radiological Health (CDRH), regulates medical devices
and radiation-emitting products.1 The 510(k) clearance process,
also called premarket notification, has become a major component of the
medical-device regulatory framework2 in the United States. In passing the
Medical Device Amendments of 1976, Congress intended the 510(k) pro-
cess to be a short-term expedient to facilitate the agency’s formidable task
of classifying all marketed devices according to risk, reviewing high-risk
medical devices on the market at that time for safety and effectiveness, and
facilitating the entry of new devices until classification and review processes
were in place. Until then, medical devices generally had not undergone pre-
market review3 by the FDA. The 510(k) clearance process was established
to permit new medical devices to be brought to market by demonstrating
only that they were substantially equivalent4 to already currently marketed
devices, which were referred to as predicates.
In recent years, policy-makers, scientists, and others have expressed
concern that the 510(k) clearance process is neither making safe and effec-
1The FDA’s Center for Biologics Evaluation and Research regulates some medical devices,
which involve blood, cellular products, and tissues. The present report pertains only to medical
devices under the jurisdiction of CDRH.
2In this report, the phrase regulatory framework is defined as including both premarket and
postmarket activities. It covers the entire product life cycle of devices.
3In this report, premarket review refers to FDA oversight that occurs before devices enter
the market. Premarket review of devices includes both the 510(k) clearance process and the
premarket approval process.
4The concept of substantial equivalence is discussed in later chapters.
15
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16 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
tive devices available to patients nor fostering innovation in the medical-
device industry.5 In the past several years, that issue has received attention
in the press because of recognized or potential problems with several devices
that had been cleared through the 510(k) process, including an artificial hip
(Meier, 2010), a patch for injured knees (Harris, 2010a; Mundy and Favole,
2009; Stein, 2010), surgical mesh (Bloomberg News, 2008), and medical-
tubing connectors (Harris, 2010b; Shuren, 2010).
In September 2009, the FDA asked the Institute of Medicine (IOM) to
review the 510(k) clearance process for medical devices and to answer two
questions:
• oes the current 510(k) clearance process protect patients optimally
D
and promote innovation in support of public health?
• f not, what legislative, regulatory, or administrative changes are
I
recommended to achieve the goals of the 510(k) clearance process
optimally?
In response to the FDA’s request, IOM appointed the Committee on
the Public Health Effectiveness of the FDA 510(k) Clearance Process. This
report summarizes the committee’s review of the 510(k) clearance process,
its conclusions on whether the process is protecting patients optimally and
promoting innovation, and its recommendations.
This chapter provides a brief overview of medical devices and of the
challenges associated with regulating them. It describes the general approach
used by the committee to complete its challenging task and includes a discus-
sion of changes that CDRH is making in the 510(k) program. The chapter
ends with a roadmap for the rest of the report.
WHAT IS A MEDICAL DEVICE?
The Federal Food, Drug, and Cosmetic Act (FFDCA)6 defines a device
as an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any component,
part, or accessory, which is
• ecognized in the official National Formulary, or the US Pharmaco-
R
peia, or any supplement to them,
5For example, letter from Representatives Henry A. Waxman, Bart Stupak, and Frank
Pallone, Jr., Committee on Energy and Commerce, US House of Representatives, to Joshua
M. Sharfstein, Principal Deputy Commissioner, US Food and Drug Administration (May 11,
2009); letter from Carmella Bocchino, America’s Health Insurance Plans, to FDA, Docket
FDA-2010-N-0054, Document FDA-2010-N-0054-0047 (March 19, 2010).
6Federal Food, Drug, and Cosmetic Act §201(h), 21 USC § 321(h) (2006).
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17
INTRODUCTION
• ntended for use in the diagnosis of disease or other conditions, or
I
in the cure, mitigation, treatment, or prevention of disease, in man
or other animals, or
• ntended to affect the structure or any function of the body of man
I
or other animals, and which does not achieve its primary intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes.
An enormous variety of medical devices are available to physicians,
patients, and other consumers. As apparent from the FFDCA definition,
medical devices can range from such simple tools as tongue depressors and
bandages to such complex or life-saving equipment as pacemakers, cochlear
implants, and heart–lung machines. Medical devices are used to diagnose,
treat for, and prevent disease. They are used in healthcare facilities—such as
hospitals, physicians’ offices, and nursing homes—and at home.
THE CHALLENGE OF REGULATING MEDICAL DEVICES
A number of actors—including medical-device companies, regulators
(the FDA), payers (such as the Centers for Medicare and Medicaid Services
and private health insurers), and consumers (healthcare providers, health-
care facilities, and patients)—are involved in bringing medical devices to
market (IOM, 2010). Medical-device companies, which develop new devices
and iterative versions of existing devices, expect a regulatory process that
is reasonable, fair, and timely. The FDA seeks to protect and promote the
public’s health by ensuring that safe and effective medical devices continue
to be made available to consumers in a timely manner without unreasonable
cost to industry. Payers and consumers expect that the regulatory process
will provide reasonable assurance that marketed medical devices are safe
and effective.
Congress, recognizing that devices are fundamentally different from
drugs, crafted legislation to regulate devices according to a framework
different from that used to regulate drugs. Devices and drugs differ in
several ways. Devices tend to have shorter product life cycles than drugs.
Incremental changes in devices are common, whereas a change in a drug
alters its molecular structure and in effect creates a new drug. Drugs may
be used by thousands or millions of consumers; but many devices are used
by only a small number of patients, so large premarket randomized, con-
trolled studies to detect rare events or small differences between products
may not be feasible. The technology of medical devices changes rapidly, so
long-term premarket studies to detect risks that emerge slowly are difficult
or impossible. Although the committee reviewed some aspects of regulation
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18 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
of drugs as part of its work, it acknowledged from the outset that because
of profound differences between devices and drugs, different regulatory
frameworks are required.
The committee, for purposes of its work, defined safety, effectiveness,
and innovation, all terms used in the statement of task. The committee’s
understandings of the concepts of reasonable assurance of safety and of
effectiveness are derived from the FFDCA and Part 860 of the Code of
Federal Regulations.7 A device is considered to provide reasonable assur-
ance of safety when it can be determined, on the basis of valid scientific
evidence, that the probable benefits to health from use of the device for
its intended uses and conditions of use when accompanied by adequate
directions and warnings against unsafe use outweigh any probable risks. A
device is considered to provide reasonable assurance of effectiveness when
it can be determined, on the basis of valid scientific evidence, that use of the
device for its intended uses under the conditions prescribed, recommended,
or suggested in its labeling will provide clinically significant results. The
committee believes that the device should provide results that are not just
clinically significant but beneficial to patients. The committee also took into
consideration the Agency for Healthcare Research and Quality (AHRQ)
definition of effectiveness (AHRQ, 2011). AHRQ bases effectiveness on
“whether a drug or other treatment works in real life. Effectiveness stud-
ies of drugs look at whether they work when they are used the way that
most people take them. Effectiveness means that most people who have the
disease would improve if they used the treatment.” That definition applies
to devices as well as to drugs. The committee took a broader view than the
AHRQ definition. It recognizes that not all devices are used as therapeutics
(for example, in vivo or in vitro diagnostic devices). In that circumstance,
effectiveness could be based on whether the device provides information that
contributes to medical decision-making. The committee also recognizes that
not all device-based therapies are directed toward curative outcomes or an
improvement in health status. They can be used to slow the progression of
disease or stabilize chronic debilitating diseases. In such cases, effectiveness
could be based on whether the device-based therapy produces some benefit
relative to the natural history of the underlying disease. Effectiveness must
be differentiated from efficacy, which AHRQ bases on “whether a drug or
other treatment works under the best possible conditions [for example, a
clinical trial].” It should be noted, therefore, that premarket clinical trials
actually measure efficacy, whereas data derived from postmarketing sur-
veillance (for example, in registries) measure effectiveness. A mandate to
ensure effectiveness must by definition measure utility in a “real-world”
environment.
7FFDCA § 513(a)(3), 21 USC § 360c(a)(3) (2006); 21 CFR § 860.7(e)(1).
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19
INTRODUCTION
Defining innovation is more challenging. Views on what constitutes
innovation vary widely. Various types of changes in medical devices can
be considered innovative, from truly novel changes to minor changes to
changes that may not alter the functionality of a device but reduce its cost
or extend its availability and thereby allow increased access. In the context
of the present report, the committee defined innovation as something that
improves the quality of, efficiency of, or access to healthcare. Class II de-
vices do not need to be shown to be innovative to be cleared for marketing.
Premarket regulation of moderate-risk devices can facilitate innovation that
improves public health by making safe and effective devices available to
consumers in a timely manner. More discussion of innovation is presented
in Chapter 6.
THE COMMITTEE’S APPROACH TO ITS TASK
The committee’s work involved gathering information, reviewing evi-
dence, and formulating, deliberating on, and coming to consensus on
findings, conclusions, and recommendations. This report summarizes the
committee’s work and presents its conclusions and recommendations.
The committee met in person six times from March 2010 to January
2011. At the March meeting, the committee held a public session to discuss
its charge with CDRH, the sponsor of its study; in June and July 2010,
it hosted public workshops. In closed session, the committee planned the
workshops, reviewed evidence, and deliberated and reached consensus on
its findings, conclusions, and recommendations. The committee considered
many possible avenues as it responded to its task. The conclusions and
recommendations included in this report were selected on the basis of the
strength of the evidence and the committee members’ expert judgment.
The committee found that it was not possible to review the 510(k) clear-
ance process in isolation from other components of medical-device regula-
tion and oversight. Therefore, although some of the topics included in the
present report are not explicitly parts of the 510(k) clearance process, they
are related to the FDA’s ability to identify and address safety and effective-
ness concerns about medical devices that emerge throughout their life cycles.
Data-Collection Efforts
The committee took a multipronged approach to collecting information.
It hosted two public workshops, in June and July 2010, on a number of
topics related to medical-device regulation. Topics covered during the June
workshop included the legislative history of the 510(k) clearance process
and its current structure, the structure of the medical-device industry and
how it is affected by regulation, the regulation of medical devices globally,
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20 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
and consumer concerns. Members of the public were invited to give com-
ments. The July workshop dealt with postmarketing surveillance of and
reporting of adverse events related to medical devices and with several other
topics of interest to the committee, such as risks associated with software
in medical devices. The committee commissioned four papers, which were
presented at the workshops. Summaries of the presentations and discussions
at the workshops have been published (IOM, 2010, 2011), and the commis-
sioned papers are included in the workshop summaries.
Other means of information-gathering included extensive searches of
the medical, scientific, and legal literature, review of information on in-
novation, review of FDA dockets related to the CDRH internal review of
the 510(k) clearance process, and review of CDRH’s Preliminary Internal
Evaluations, Volumes 1 and 2 and other government reports, such as re-
ports from the Government Accountability Office (GAO, 2009a, 2009b,
2009c, 2009d) and the Department of Health and Human Services Office
of the Inspector General (OIG, 2009). CDRH responded promptly to the
committee’s many requests for information on the center’s policies and pro-
cedures. Experts in the US and global medical-device field were contacted
for additional information. And members of the public were encouraged to
submit comments to the committee during the study process; the committee
received and reviewed a number of such comments.
Limitations of Data-Collection Efforts
Limitations of the committee’s data-collection activities affected the
committee’s ability to assess the quality of both the 510(k) submissions and
CDRH’s reviews of those submissions systematically. Because of limitations
in the types of information captured in CDRH’s databases, the committee
could not review systematically such information as the types of data (for
example, clinical data and bench-testing data) included in 510(k) submis-
sions. The limitations in the FDA’s information-technology systems are
discussed further in Chapters 3 and 4.
The committee also considered conducting a systematic file review of
510(k) submissions and CDRH reviews. However, because of FDA statutory
and regulatory protections for 510(k) submitter proprietary information,
the committee was not able to review complete 510(k) submissions. As a re-
sult, a comprehensive file review of 510(k) submissions was not conducted.
The committee was able to review several redacted 510(k) submissions
supplied by CDRH. The committee also used information from government
organizations (for example, GAO) and CDRH (for its internal preliminary
evaluations) that had access to complete 510(k) submissions, CDRH’s re-
views, and other information. The committee found those analyses to be
methodologically sound and used them as part of its evidence base.
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21
INTRODUCTION
ATTRIBUTES OF AN IDEAL MEDICAL-
DEVICE REGULATORY SYSTEM
To be able to determine whether the 510(k) clearance process is optimal-
ly protecting patients and promoting innovation in support of public health,
the committee first had to define the attributes of an ideal medical-device
regulatory system. It started by defining two goals of medical-device regu-
lation: to provide reasonable assurance that marketed devices, throughout
their life cycles, are safe and effective according to current standards for the
clinical indication at the time of use and to facilitate innovation by allowing
prompt access of devices to the market. The committee next developed a
list of six attributes, which are presented in Box 1-1. The attributes are not
presented in any priority order.
The committee defined the attributes as follows. A medical-device
regulatory system that is based on sound science uses appropriate scientific
methods and evolving, state-of-the-art evidentiary standards; is data-driven;
and provides for linkage of premarket and postmarketing information. A
clear, predictable, straightforward, and fair regulatory system is accessible,
responsive, transparent, reproducible, efficient (for example, it does not
incur unnecessary costs or time), and credible; and it has conflict-resolution
policies in place. A self-sustaining and self-improving (that is, robust)
regulatory system uses continuous quality improvement and ensures the
integrity of data and decision-making. A process that facilitates innovation
is adaptable so that emerging technologies and policies can be incorporated
and unforeseen circumstances can be addressed. The use of appropriate
regulatory standards and authorities throughout a device’s life cycle should
BOX 1-1
Attributes of an Ideal Medical‑Device Regulatory System
• T
he process should be based on sound science.
• T
he process should be clear, predictable, straightforward, and fair.
• T
he process should be self-sustaining and self-improving.
• T
he process should facilitate innovation that improves public health
by making medical devices available in a timely manner and ensuring
their safety and effectiveness throughout their life cycle.
• he process should use relevant and appropriate regulatory authori-
T
ties and standards throughout the life cycle of devices to ensure safety
and effectiveness.
• he process should be risk-based.
T
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22 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
include risk-based premarket reviews, credible and continuous postmarket-
ing surveillance, and performance-based criteria that meet current clinical
standards for continued availability of products demonstrated to be safe
and effective. Finally, the process should incorporate risk-benefit analyses
and flexible risk-mitigation strategies (for example, devices can be made
available with special controls based on associated risks). Data and expe-
rience gathered at each stage of the product life cycle are used to inform
other stages. Data collection from postmarketing surveillance should inform
premarket review of new or modified devices.
The committee recognizes that no premarket regulatory system for
medical devices can guarantee that all devices are completely safe and effec-
tive. That would set an impossible threshold. Any regulatory system must
balance medical devices’ risks and their potential public-health benefits.
Given that a perfect premarket regulatory system is unrealistic, it is essential
to have effective postmarket oversight of medical devices.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
ACTIVITIES RELATED TO THE 510(K) PROCESS
The 510(k) process has undergone substantial changes since its incep-
tion in 1976, and it continues to evolve. In addition to commissioning the
present report, CDRH conducted an internal review of the 510(k) clearance
process during 2009–2010. To carry out its review, it appointed an internal
working group and charged it “to evaluate the 510(k) program and explore
actions CDRH could take to enhance our 510(k) decision making.” The
center’s findings and recommendations from that review were published
in CDRH Preliminary Internal Evaluations—Volume 1: 510(k) Working
Group Preliminary Report and Recommendations in August 2010 (FDA,
2010a). The focus was to be on actions that could be initiated in the short
term without changes in existing statutory authority.
The working group, through the efforts of 10 subgroups, gathered in-
formation from CDRH staff at various levels (for example, reviewers and
managers). It also queried internal databases and analyzed the data. And
it sought input from stakeholders, such as medical-industry and patient
representatives, through requests for public comments and several public
meetings.
CDRH’s report offered seven major preliminary findings and recom-
mendations were included in CDRH’s report in three categories: a rational,
well-defined, and consistently interpreted review standard; well-informed
decision-making; and continuous quality assurance. Those findings and
recommendations are presented in Box 1-2.
At the same time that CDRH released CDRH Preliminary Internal
Evaluations—Volume I: 510(k) Working Group Preliminary Report and
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23
INTRODUCTION
Recommendations, it released a second report, CDRH Preliminary Inter-
nal Evaluations—Volume II: Task Force on the Utilization of Science in
Regulatory Decision Making Preliminary Report and Recommendations.
Volume II contains findings and recommendations in three major categories:
enhancing CDRH’s scientific knowledge base, applying a predictable ap-
proach to determine the appropriate response to new science, and promptly
communicating current or evolving thinking to all affected parties (FDA,
2010b). Although this volume is not directly related to the 510(k) clearance
process, it contains information that has the potential to affect the process.
The committee reviewed both volumes as part of its evidence base.
After releasing its preliminary internal evaluations, CDRH published
a notice in the Federal Register to request public comments on them. In
January 2011, CDRH announced that it was moving forward with several
of its recommendations (FDA, 2011). Twenty-five actions are scheduled to
take place in 2011. Specific steps include
• treamlining the review process for innovative, lower-risk products.
S
• ublishing guidance for industry to clarify when clinical data should
P
be submitted to increase predictability and transparency.
• eveloping a network of external experts who can use their knowl-
D
edge and experience to help the agency to address important scientific
issues regarding new medical-device technologies.
• stablishing a new Center Science Council of senior FDA experts
E
in CDRH to ensure more timely and consistent science-based
decision-making.
• stablishing a public database of important device information, such
E
as medical-device labeling and summaries of the basis of FDA’s deci-
sions to clear specific devices.
• equiring a brief description of scientific information known to
R
manufacturers regarding the safety and effectiveness of select higher-
risk devices case by case basis through device-specific guidance.
CDRH identified seven recommendations that it determined, on the
basis of comments received from members of the public, raised substantial
stakeholder concerns. The issues addressed by those recommendations are
• efining the scope and grounds for CDRH to exercise its authority
D
to rescind a 510(k) clearance fully or partially.
• eeking greater authority to require postmarket surveillance studies
S
as a condition of clearance for some devices.
• eveloping guidance defining Class IIb devices for which clinical
D
information, manufacturing information, or, potentially, additional
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24 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
BOX 1-2
CDRH’s Preliminary Finding and Recommendations from Its
Review of the 510(k) Clearance Process
A Rational, Well‑Defined, and Consistently Interpreted Review
Standard
Finding 1: There is insufficient clarity with respect to pivotal terms
in the definition of “substantial equivalence.”
Recommendation 1: CDRH should clarify the meaning of “sub-
stantial equivalence” through guidance and training for reviewers,
managers, and industry.
Finding 2: CDRH’s current practice allows for the use of some types
of predicates that may not be appropriate.
Recommendation 2: CDRH should explore the development of
guidance and regulation to provide greater assurance that any com-
parison of a new device to a predicate is valid and well-reasoned.
Finding 3: Although there exists an alternative regulatory pathway
for devices that lack a clear predicate but whose risks do not warrant
Class III controls (i.e., the process for Evaluation of Automatic Class
III Designation, also known as the de novo classification process),
this pathway, as currently implemented, is inefficient and has not
been utilized optimally across the Center.
Recommendation 3: CDRH should reform its implementation of the
de novo classification process to provide a practical, risk-based op-
tion that affords an appropriate level of review and regulatory control
for eligible devices.
Well‑Informed Decision Making
Finding 4: It is challenging for CDRH to obtain, in an efficient and
predictable manner, the information it needs to make well-supported
evaluation in the postmarket setting would typically be necessary to
support a determination of substantial equivalence.
• C
larifying when a device should no longer be available for use as a
predicate.
• C
onsolidating the concepts of “indications for use” and “intended
use” into a single term, “intended use.”
• R
equiring each 510(k) submitter to keep at least one unit of the de-
vice that is under review available for CDRH to access on request.
• P
ursuing a statutory amendment that would provide the agency with
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25
INTRODUCTION
premarket decisions and assure that each new or modified 510(k)
device is substantially equivalent to a valid predicate.
Recommendation 4: CDRH should take steps through guidance
and regulation to facilitate the efficient submission of high-quality
510(k) device information, in part by better clarifying and more ef-
fectively communicating its evidentiary expectations through the
creation, via guidance, of a new “Class IIb” device subset.
Finding 5: Limitations in CDRH’s information technology and knowl-
edge management infrastructure and tools make it challenging for
Center staff and 510(k) submitters to access meaningful medical
device information that would support better-informed and more
predictable decision-making.
Recommendation 5: CDRH should take steps to enhance its inter-
nal and public information systems and databases to provide easier
access to more complete information about 510(k) devices and previ-
ous clearance decisions.
Continuous Quality‑Assurance
Finding 6: Variations in the expertise, experience, and training of
reviewers and managers, including third-party reviewers, may con-
tribute to inconsistency or uncertainty in 510(k) decision-making.
Recommendation 6: CDRH should enhance training, professional
development, and knowledge-sharing among reviewers and manag-
ers, in order to support consistent, high-quality 510(k) reviews.
Finding 7: CDRH does not currently have an adequate mechanism
to regularly assess the quality, consistency, and effectiveness of the
510(k) program.
Recommendation 7: CDRH should enhance its systems and pro-
gram metrics to support continuous quality-assurance.
SOURCE: FDA, 2010b.
the express authority to consider an off-label use when determining
the “intended use” of a device.
In its announcement, CDRH stated that it will “give the IOM an opportu-
nity to provide feedback on selected recommendations should they decide
to address these recommendations in their report” (FDA, 2011). CDRH’s
announcement came toward the end of the committee’s work. Because of
time constraints, the committee was unable to study fully the seven recom-
mendations that CDRH referred to the committee. The committee did,
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26 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
however, address many of the broader issues related to those recommenda-
tions in this report.
ORGANIZATION OF THE REPORT
Chapters 2–6 of this report summarize the committee’s review of the
evidence and lay out the logic for how it came to its conclusions and rec-
ommendations. Chapter 2 provides a brief history of federal legislation and
regulation of medical devices, which has undergone many changes since
devices were first regulated in 1938. Chapter 3 reviews how medical devices
in general are regulated in the United States. Chapter 4 explores the 510(k)
process in depth. Postmarketing surveillance is covered in Chapter 5. Chap-
ter 6 discusses the environment within which medical devices are developed
and how advancing technology is affecting how they are regulated. Finally,
Chapter 7 contains the committee’s conclusions and recommendations. The
report has two appendixes. Readers who want a fuller understanding of
federal legislation and regulation of medical devices are encouraged to read
Appendix A. Appendix B contains biographic information on the commit-
tee members.
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